Ropinirole ER 8mg Tablets
It is used to treat Parkinson's disease.
Drug Class
Antiparkinsonian agent
Pharmacologic Class
Non-ergoline dopamine agonist
Pregnancy Category
Category C
FDA Approved
Jun 2007
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ropinirole is a medication used to treat Parkinson's disease. It works by acting like a natural chemical in your brain called dopamine, which helps control movement. The extended-release (ER) form is taken once a day to provide a steady effect.
How to Use This Medicine
Taking Your Medication
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food. Swallow the tablet whole - do not chew, break, or crush it.
If you have a medical condition like diarrhea that causes the medication to pass through your body too quickly, you may notice what looks like the tablet in your stool. If this happens, consult your doctor.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. If you need to stop taking the medication, talk to your doctor first. You may need to restart at a lower dose and gradually increase it.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep the container tightly closed and store it in a safe place, out of the reach of children and pets. Do not store your medication in the bathroom.
When you're finished with your medication or it's expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you're unsure about how to dispose of your medication, ask your pharmacist. You may also want to check if there are any drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. If it's close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time or take extra doses.
If you miss several days of medication, contact your doctor to find out how to restart your treatment.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food. Swallow the tablet whole - do not chew, break, or crush it.
If you have a medical condition like diarrhea that causes the medication to pass through your body too quickly, you may notice what looks like the tablet in your stool. If this happens, consult your doctor.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. If you need to stop taking the medication, talk to your doctor first. You may need to restart at a lower dose and gradually increase it.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep the container tightly closed and store it in a safe place, out of the reach of children and pets. Do not store your medication in the bathroom.
When you're finished with your medication or it's expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. If you're unsure about how to dispose of your medication, ask your pharmacist. You may also want to check if there are any drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. If it's close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time or take extra doses.
If you miss several days of medication, contact your doctor to find out how to restart your treatment.
Lifestyle & Tips
- Take Ropinirole ER once daily, at approximately the same time each day. It can be taken with or without food, but taking it with food may help if you experience nausea.
- Swallow the tablet whole. Do not crush, chew, or divide the extended-release tablet, as this will cause the medication to be released too quickly.
- Avoid or limit alcohol consumption while taking this medication, as it can increase drowsiness.
- Be cautious when driving or operating machinery, especially when starting treatment or increasing the dose, as this medication can cause sudden sleep attacks or extreme drowsiness.
- Do not stop taking this medication suddenly without consulting your doctor, as it can lead to serious withdrawal symptoms.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
For Parkinson's Disease: Initial dose 2 mg once daily for 1 to 2 weeks, then may increase by 2 mg/day increments at weekly or longer intervals based on response and tolerability. Typical maintenance dose range is 4 mg to 24 mg once daily.
Dose Range:
2 - 24 mg
Condition-Specific Dosing:
Parkinson's Disease:
Initial: 2 mg once daily for 1-2 weeks. Titration: Increase by 2 mg/day increments at weekly or longer intervals. Maintenance: 4-24 mg once daily. Max: 24 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment required.
Moderate:
No dosage adjustment required.
Severe:
No dosage adjustment required for patients with creatinine clearance of 30-50 mL/min. For patients with CrCl <30 mL/min, consider dose reduction or slower titration.
Dialysis:
Not studied in patients on dialysis. Use with caution.
Hepatic Impairment:
Mild:
No dosage adjustment required.
Moderate:
No specific dosage adjustment recommendations; use with caution.
Severe:
Not studied in severe hepatic impairment; use with caution.
Pharmacology
Mechanism of Action
Ropinirole is a non-ergoline dopamine agonist with high affinity for D2 and D3 dopamine receptors. It is believed to stimulate postsynaptic D2-type receptors in the caudate-putamen in the brain, thereby alleviating the motor symptoms of Parkinson's disease.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 55%
Tmax:
6-10 hours (extended-release)
FoodEffect:
Food does not affect the AUC or Tmax of ropinirole ER, but Cmax may be slightly reduced.
Distribution:
Vd:
Approximately 7.5 L/kg
ProteinBinding:
Approximately 37%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 6 hours (terminal half-life of parent drug)
Clearance:
Approximately 40 L/hr
ExcretionRoute:
Urine (primarily as metabolites)
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
Requires titration for full therapeutic effect; not an acute onset medication.
PeakEffect:
Achieved after several weeks of titration to an effective maintenance dose.
DurationOfAction:
24 hours (extended-release formulation)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain or pelvic pain
Confusion, difficulty focusing, or changes in behavior
Strong, uncontrollable urges (e.g., eating, gambling, sex, or spending money)
Changes in eyesight
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Hallucinations (seeing or hearing things that are not there)
Mood changes
Shortness of breath
New or worsening trouble controlling body movements
Swelling
Burning, numbness, or tingling sensations that are not normal
Memory problems or loss
Fever
Muscle stiffness
Some people have experienced sudden sleepiness during activities like driving, eating, or talking, even if they felt alert beforehand. This can occur up to 1 year after starting the medication. If you experience sudden sleepiness, do not drive or engage in activities that require alertness. Contact your doctor immediately if you experience sudden sleepiness or excessive sleepiness.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Dizziness
Sleepiness
Fatigue
Weakness
Headache
Excessive sweating
Dry mouth
Joint pain
Nervousness or excitability
Shakiness
Anxiety
Nose or throat irritation
* Back pain
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Signs of a urinary tract infection (UTI), such as:
+ Blood in the urine
+ Burning or pain when passing urine
+ Frequent or urgent need to urinate
+ Fever
+ Lower stomach pain or pelvic pain
Confusion, difficulty focusing, or changes in behavior
Strong, uncontrollable urges (e.g., eating, gambling, sex, or spending money)
Changes in eyesight
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Hallucinations (seeing or hearing things that are not there)
Mood changes
Shortness of breath
New or worsening trouble controlling body movements
Swelling
Burning, numbness, or tingling sensations that are not normal
Memory problems or loss
Fever
Muscle stiffness
Some people have experienced sudden sleepiness during activities like driving, eating, or talking, even if they felt alert beforehand. This can occur up to 1 year after starting the medication. If you experience sudden sleepiness, do not drive or engage in activities that require alertness. Contact your doctor immediately if you experience sudden sleepiness or excessive sleepiness.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Dizziness
Sleepiness
Fatigue
Weakness
Headache
Excessive sweating
Dry mouth
Joint pain
Nervousness or excitability
Shakiness
Anxiety
Nose or throat irritation
* Back pain
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Sudden onset of sleep during daily activities (even without warning)
- Severe dizziness or fainting, especially when standing up (orthostatic hypotension)
- Hallucinations (seeing or hearing things that are not real)
- Unusual urges or behaviors, such as increased gambling, increased sexual urges, compulsive shopping, or binge eating
- New or worsening uncontrolled movements (dyskinesia)
- Unexplained muscle stiffness, high fever, confusion, or sweating (signs of neuroleptic malignant syndrome-like symptoms if stopped abruptly)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking another medication that contains the same active ingredient as this drug.
Potential interactions with other medications or health conditions. To ensure safe treatment, disclose all of your:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
Any existing health problems, as they may affect the safety of taking this medication.
Remember, it is crucial to verify that it is safe to take this medication with all of your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking another medication that contains the same active ingredient as this drug.
Potential interactions with other medications or health conditions. To ensure safe treatment, disclose all of your:
+ Prescription medications
+ Over-the-counter (OTC) medications
+ Natural products
+ Vitamins
Any existing health problems, as they may affect the safety of taking this medication.
Remember, it is crucial to verify that it is safe to take this medication with all of your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When getting up from a sitting or lying down position, rise slowly to minimize the risk of dizziness or fainting. Be cautious when climbing stairs to prevent accidents.
Do not discontinue this medication without consulting your doctor, as stopping it abruptly may lead to withdrawal symptoms. If you need to stop taking this medication, follow the dosage reduction schedule recommended by your doctor. Monitor yourself for signs of withdrawal, such as fever, confusion, severe muscle stiffness, apathy, anxiety, depression, fatigue, sleep disturbances, sweating, or pain, and contact your doctor immediately if you experience any of these symptoms.
If you start or stop smoking, notify your doctor, as this may necessitate an adjustment in your medication dosage. Before consuming alcohol, marijuana, or other cannabis products, or taking prescription or over-the-counter medications that may cause drowsiness, consult with your doctor.
Regularly check your blood pressure and heart rate as instructed by your doctor. Be aware of the risk of neuroleptic malignant syndrome (NMS), a potentially life-threatening condition that may occur when medications like this one are stopped suddenly or when the dosage is reduced. If you experience symptoms such as fever, muscle cramps or stiffness, dizziness, severe headache, confusion, altered mental status, rapid or irregular heartbeat, or excessive sweating, contact your doctor right away.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women, or those planning to become pregnant, should discuss the benefits and risks of this medication with their doctor to make an informed decision.
To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When getting up from a sitting or lying down position, rise slowly to minimize the risk of dizziness or fainting. Be cautious when climbing stairs to prevent accidents.
Do not discontinue this medication without consulting your doctor, as stopping it abruptly may lead to withdrawal symptoms. If you need to stop taking this medication, follow the dosage reduction schedule recommended by your doctor. Monitor yourself for signs of withdrawal, such as fever, confusion, severe muscle stiffness, apathy, anxiety, depression, fatigue, sleep disturbances, sweating, or pain, and contact your doctor immediately if you experience any of these symptoms.
If you start or stop smoking, notify your doctor, as this may necessitate an adjustment in your medication dosage. Before consuming alcohol, marijuana, or other cannabis products, or taking prescription or over-the-counter medications that may cause drowsiness, consult with your doctor.
Regularly check your blood pressure and heart rate as instructed by your doctor. Be aware of the risk of neuroleptic malignant syndrome (NMS), a potentially life-threatening condition that may occur when medications like this one are stopped suddenly or when the dosage is reduced. If you experience symptoms such as fever, muscle cramps or stiffness, dizziness, severe headache, confusion, altered mental status, rapid or irregular heartbeat, or excessive sweating, contact your doctor right away.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women, or those planning to become pregnant, should discuss the benefits and risks of this medication with their doctor to make an informed decision.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Dizziness
- Somnolence (extreme drowsiness)
- Dyskinesia (involuntary movements)
- Orthostatic hypotension (low blood pressure upon standing)
- Hallucinations
- Confusion
- Psychosis
What to Do:
Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is supportive and may include gastric lavage, emesis, IV fluids, and dopamine antagonists (if severe psychosis/hallucinations).
Drug Interactions
Major Interactions
- CYP1A2 inhibitors (e.g., ciprofloxacin, fluvoxamine): May significantly increase ropinirole plasma concentrations, requiring dose reduction of ropinirole.
- Dopamine antagonists (e.g., antipsychotics like haloperidol, chlorpromazine; metoclopramide): May reduce the efficacy of ropinirole.
Moderate Interactions
- Estrogens (e.g., hormone replacement therapy, oral contraceptives): May reduce ropinirole clearance, potentially requiring ropinirole dose adjustment.
- CNS depressants (e.g., alcohol, sedatives, hypnotics, anxiolytics): May potentiate the sedative effects of ropinirole.
Monitoring
Baseline Monitoring
Orthostatic blood pressure
Rationale: To assess risk of orthostatic hypotension, a common side effect.
Timing: Before initiation and during titration.
Renal function (CrCl)
Rationale: To guide dose adjustments in severe renal impairment, though generally not required for mild-moderate.
Timing: Before initiation if renal impairment is suspected.
Psychiatric history
Rationale: To identify predisposition to impulse control disorders or psychosis.
Timing: Before initiation.
Routine Monitoring
Efficacy (motor symptoms of PD)
Frequency: Regularly during titration and maintenance
Target: Improved motor function, reduced 'off' time
Action Threshold: Lack of improvement or worsening symptoms may require dose adjustment or alternative therapy.
Orthostatic blood pressure
Frequency: Periodically, especially during dose titration
Target: Stable blood pressure without symptomatic drops
Action Threshold: Symptomatic hypotension (dizziness, lightheadedness, syncope) requires dose reduction or discontinuation.
Excessive daytime sleepiness/sudden sleep attacks
Frequency: Regularly
Target: Alertness during waking hours
Action Threshold: Reported somnolence or sudden sleep attacks require dose reduction or discontinuation, and patient counseling on driving/operating machinery.
Impulse control disorders (e.g., pathological gambling, hypersexuality, compulsive shopping, binge eating)
Frequency: Regularly, inquire directly
Target: Absence of new or worsening compulsive behaviors
Action Threshold: Development of new or worsening compulsive behaviors requires dose reduction, discontinuation, or referral to a specialist.
Hallucinations/Psychotic-like behavior
Frequency: Regularly
Target: Absence of hallucinations or psychosis
Action Threshold: Development of hallucinations or psychotic symptoms requires dose reduction or discontinuation.
Dyskinesia
Frequency: Regularly
Target: Minimal or tolerable involuntary movements
Action Threshold: Worsening or bothersome dyskinesia may require dose adjustment or addition of other agents.
Symptom Monitoring
- Dizziness
- Lightheadedness
- Fainting (syncope)
- Excessive daytime sleepiness
- Sudden onset of sleep
- Hallucinations
- Confusion
- Unusual urges or behaviors (e.g., gambling, hypersexuality, compulsive shopping, binge eating)
- Involuntary movements (dyskinesia)
- Nausea
- Vomiting
- Swelling in legs/feet
Special Patient Groups
Pregnancy
Ropinirole is classified as Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for developmental toxicity observed in animal studies at doses higher than human therapeutic doses.
Second Trimester:
Potential for developmental toxicity observed in animal studies at doses higher than human therapeutic doses.
Third Trimester:
Potential for developmental toxicity observed in animal studies at doses higher than human therapeutic doses.
Lactation
Ropinirole is not recommended during breastfeeding. It is known to inhibit prolactin secretion in humans and may inhibit lactation. It is also excreted into milk in animals, and potential for serious adverse effects in breastfed infants exists.
Infant Risk:
L3 (Moderately Safe) - Potential for inhibition of lactation and unknown effects on infant. Weigh risks vs. benefits; consider alternative or discontinue drug/breastfeeding.
Pediatric Use
Safety and effectiveness of ropinirole in pediatric patients have not been established. It is not indicated for use in this population.
Geriatric Use
Geriatric patients may be more sensitive to the effects of ropinirole, particularly regarding hallucinations and orthostatic hypotension. Start with lower doses and titrate slowly. Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Ropinirole ER is for once-daily dosing. Emphasize not to crush, chew, or divide the tablets.
- Counsel patients extensively on the risk of sudden sleep attacks and impulse control disorders. These can occur without warning and may require dose adjustment or discontinuation.
- Titration is critical to minimize side effects, especially nausea, dizziness, and somnolence. Patients should be advised to follow the titration schedule strictly.
- Orthostatic hypotension is a common side effect; advise patients to rise slowly from a sitting or lying position.
- Do not discontinue ropinirole abruptly, as this can lead to a withdrawal syndrome resembling neuroleptic malignant syndrome (fever, rigidity, altered mental status, autonomic instability).
Alternative Therapies
- Other non-ergoline dopamine agonists (e.g., pramipexole, rotigotine)
- Levodopa/carbidopa (often considered first-line for motor symptoms in older patients or those with more severe PD)
- MAO-B inhibitors (e.g., selegiline, rasagiline)
- COMT inhibitors (e.g., entacapone, opicapone)
- Amantadine
Cost & Coverage
Average Cost:
Varies widely, typically $50-$300+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 or 4 (brand) depending on insurance plan
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.